Canada Gazette, Part I, Volume 151, Number 3: GOVERNMENT NOTICES
January 21, 2017
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice of intent to amend the Domestic Substances List under subsection 112(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 106(3) of that Act applies to the living organisms set out in this Notice
Whereas the living organisms Aspergillus oryzae ATCC 11866 and Pseudomonas putida ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 are specified on the Domestic Substances List; (see footnote 1)
Whereas the Minister of the Environment and the Minister of Health (the ministers) have conducted screening assessments on these living organisms under section 74 of the Canadian Environmental Protection Act, 1999; (see footnote 2)
And whereas the ministers suspect that the information concerning a significant new activity in relation to these living organisms may contribute to determining the circumstances in which the living organisms are toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, notice is hereby given that the Minister of the Environment intends to amend the Domestic Substances List pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 106(3) of that Act applies to any significant new activities relating to these living organisms, as set out in this Notice.
Public comment period
Any person may, within 60 days of publication of this Notice, file with the Minister of the Environment comments with respect to this proposal. All comments must cite the Canada Gazette, Part I, and the date of publication of this Notice and be sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca.
The final screening assessments for these living organisms may be obtained from the Government of Canada's Chemical Substances website (www.chemicalsubstanceschimiques.gc.ca).
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this Notice may submit with the information a request that it be treated as confidential.
George Enei
Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment
ANNEX
1. Part 5 of the Domestic Substances List is proposed to be amended by deleting the following under the heading “Organisms/Organismes”:
Aspergillus oryzae ATCC 11866
Pseudomonas putida ATCC 12633
Pseudomonas putida ATCC 31483
Pseudomonas putida ATCC 31800
Pseudomonas putida ATCC 700369
| Column 1 Living organism |
Column 2 Significant new activity for which living organism is subject to subsection 106(3) of the Act |
|---|---|
Aspergillus oryzae |
1. In relation to the living organism Aspergillus oryzae ATCC 11866,
|
2. Despite item 1, any activity involving the use of the living organism in a contained facility, within a health care facility, that provides a level of containment that is in accordance with the requirements of containment level 2 or a higher level of containment, as set out in the Canadian Biosafety Standard, as amended from time to time, is not a significant new activity. |
|
3. For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the commencement of the proposed significant new activity:
|
|
4. The above information will be assessed within 120 days after the day on which it is received by the Minister. |
|
Pseudomonas putida Pseudomonas putida Pseudomonas putida Pseudomonas putida |
1. The use of any of the living organisms in column 1, opposite to this section, in
|
2. Despite item 1, any activity involving the use of any of the living organisms in a contained facility, within a health care facility or blood donor clinic, that provides a level of containment that is in accordance with the requirements of containment level 2 or a higher level of containment, as set out in the Canadian Biosafety Standard, as amended from time to time, is not a significant new activity. |
|
3. For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the commencement of the proposed significant new activity:
|
|
4. The above information will be assessed within 120 days after the day on which it is received by the Minister. |
Coming into Force
3. The Order would come into force on the day on which it is registered.
EXPLANATORY NOTE
(This explanatory note is not part of the Notice of Intent.)
Description
This Notice of Intent (NOI) is an opportunity for the public to comment on the proposed amendments to the Domestic Substances List (DSL) to apply the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) (see footnote 3) to the living organisms Aspergillus oryzae (A. oryzae) ATCC 11866 and Pseudomonas putida (P. putida) ATCC 12633, ATCC 31483, ATCC 31800 and ATCC 700369.
Within 60 days of publication of the NOI, any person may submit comments to the Minister of the Environment. These comments will be taken into consideration during the development of the Order amending the DSL to apply the SNAc provisions to these living organisms.
A number of other SNAc instruments are to be published in the near future that will also target consumer products. As a result, stakeholder input provided in response to the consumer product language proposed in this NOI may not be reflected in upcoming NOIs due to publication timelines. However, any input received will be taken into consideration during the development of all related notices and orders that pertain to consumer products.
The DSL amendments are not in force until the Order is adopted by the Minister pursuant to subsection 112(3) of CEPA. The Order must be published in the Canada Gazette, Part II.
Applicability of the proposed Order
At this time, it is proposed that the Order amending the DSL would require any person (individual or corporation) engaging in a significant new activity in relation to A. oryzae ATCC 11866 or P. putida ATCC 12633, ATCC 31483, ATCC 31800 and ATCC 700369 to submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 120 days prior to the import, manufacture or use of the living organism for the significant new activity.
Examples of potential activities with respect to A. oryzae ATCC 11866 or P. putida ATCC 12633, ATCC 31483, ATCC 31800 and ATCC 700369 requiring a SNAN would include, but would not be limited to, new activities that may pose a potential risk to susceptible humans with compromised immunity. Activities in health care settings, and also, for A. oryzae ATCC 11866, activities that would result in exposure of the general population during the use of a consumer product containing the living organism and to which the Canada Consumer Product Safety Act (CCPSA) (see footnote 4) applies, require the submission of a SNAN (see Annex A for the CCPSA definition of “consumer product” and exemptions).
Activities not subject to the proposed Order
The proposed Order would not apply to the use of the living organisms in consumer products to which the CCPSA does not apply or to uses of the living organisms that are regulated under the acts of Parliament listed in Schedule 4 of CEPA, including the Pest Control Products Act, the Seeds Act, the Fertilizers Act, the Feeds Act and the Health of Animals Act. The Order would also not apply to impurities and contaminants related to the preparation of a living organism, or, in some circumstances, to items such as wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the Order. See subsection 106(6) and section 3 of CEPA and section 2 of the Guidelines for the Notification and Testing of New Substances: Organisms for additional details. (see footnote 5)
Activities involving the use of a living organism in a contained facility that meets the requirements for containment level 2 or a higher level of containment, including as a research and development organism, would be excluded from the proposed Order. The terms “contained facility” and “research and development organism” are defined in subsection 1(1) of the New Substances Notification Regulations (Organisms). (see footnote 6)
Information to be submitted
The NOI sets out the proposed information that would need to be provided to the Minister 120 days before the day on which the living organism is imported, manufactured or used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct human health and environmental assessments within 120 days after the complete information is received.
The information requirements in the proposed Order relate to general information in respect of the living organism, details surrounding its use, and exposure information. Some of the proposed information requirements are set out in the New Substances Notification Regulations (Organisms).
Additional guidance on preparing a SNAN can be found in section 7 of the Guidelines for the Notification and Testing of New Substances: Organisms.
Compliance
When assessing whether or not a living organism is subject to SNAc provisions, (see footnote 7) a person is expected to make use of information in their possession or to which they ought to have access. The phrase “to which they ought to have access” means information in any of the notifier's offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheet (SDS). (see footnote 8)
Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products, and may not include information on microbial hazards. Therefore, an SDS may not list all product ingredients or microbial constituents that may be subject to an order due to human health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.
If any information becomes available that reasonably supports the conclusion that any of these living organisms is toxic or capable of becoming toxic, the person who is in possession of the information and is involved in activities with the living organism is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.
A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession and control of a living organism from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by the original SNAN. The Substances Management Advisory Note, “Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999,” provides more detail on this subject. (see footnote 9)
Any person who transfers the physical possession or control of a living organism subject to an order should notify all persons to whom the physical possession or control is transferred of the obligation to comply with the order, including of the obligation to notify the Minister of any significant new activity and to provide all the required information outlined above.
A pre-notification consultation (PNC) is available for notifiers during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.
Where a person has questions concerning their obligations to comply with a notice or order, or believes they may be out of compliance, or would like to request a PNC, they are encouraged to discuss their particular circumstances by contacting the Substances Management Information Line. (see footnote 10)
CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. (see footnote 11) In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent and history of compliance.
ANNEX A
Consumer Product Definition in the Canada Consumer Product Safety Act (CCPSA) (see footnote 12)
In section 2 of the CCPSA, “consumer product” means a product, including its components, parts or accessories, that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging. Section 4 of the CCPSA describes the application of the Act as follows:
Consumer products
4. (1) This Act applies to consumer products with the exception of those listed in Schedule 1.
Tobacco products
(2) This Act applies to tobacco products as defined in section 2 of the Tobacco Act but only in respect of their ignition propensity.
Natural health products
(3) For greater certainty, this Act does not apply to natural health products as defined in subsection 1(1) of the Natural Health Products Regulations made under the Food and Drugs Act.
Schedule 1 of the Canada Consumer Product Safety Act (CCPSA) [subsection 4(1) and paragraph 37(1)(c)]
1. Explosives within the meaning of section 2 of the Explosives Act.
2. Cosmetics within the meaning of section 2 of the Food and Drugs Act.
3. Devices within the meaning of section 2 of the Food and Drugs Act.
4. Drugs within the meaning of section 2 of the Food and Drugs Act.
5. Food within the meaning of section 2 of the Food and Drugs Act.
6. Pest control products within the meaning of subsection 2(1) of the Pest Control Products Act.
7. Vehicles within the meaning of section 2 of the Motor Vehicle Safety Act and a part of a vehicle that is integral to it — as it is assembled or altered before its sale to the first retail purchaser — including a part of a vehicle that replaces or alters such a part.
8. Feeds within the meaning of section 2 of the Feeds Act.
9. Fertilizers within the meaning of section 2 of the Fertilizers Act.
10. Vessels within the meaning of section 2 of the Canada Shipping Act, 2001.
11. Firearms within the meaning of section 2 of the Criminal Code.
12. Ammunition within the meaning of subsection 84(1) of the Criminal Code.
13. Cartridge magazines within the meaning of subsection 84(1) of the Criminal Code.
14. Cross-bows within the meaning of subsection 84(1) of the Criminal Code.
15. Prohibited devices within the meaning of paragraphs (a) to (d) of the definition “prohibited device” in subsection 84(1) of the Criminal Code.
16. Plants within the meaning of section 3 of the Plant Protection Act, except for Jequirity beans (abrus precatorius).
17. Seeds within the meaning of section 2 of the Seeds Act, except for Jequirity beans (abrus precatorius).
18. Controlled substances within the meaning of subsection 2(1) of the Controlled Drugs and Substances Act.
19. Aeronautical products within the meaning of subsection 3(1) of the Aeronautics Act.
20. Animals within the meaning of subsection 2(1) of the Health of Animals Act.
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of a living organism — Bacillus circulans (B. circulans) strain ATCC (see footnote 13) 9500 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas Bacillus circulans strain ATCC 9500 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft screening assessment conducted on this living organism, pursuant to paragraph 74(b) of the Act, is annexed hereby;
Whereas it is proposed to conclude that this living organism does not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on this living organism at this time under section 77 of the Act.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the draft screening assessment for Bacillus circulans strain ATCC 9500
Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on Bacillus circulans (B. circulans) strain ATCC 9500.
B. circulans is an endospore-forming bacterium that is present in many environments. It has been isolated from soils and marine water, and is found in association with plants and animals. B. circulans has properties that make it of potential use in aquaculture, bioremediation, biodegradation, water and wastewater treatment, drain cleaning and degreasing and enzyme production.
There has been no adverse effect attributed to B. circulans strain ATCC 9500 in the environment. However, in the context of experimental investigations into their biocontrol potential, some strains of B. circulans have shown pathogenic potential towards some insects and nematodes when directly inoculated with high concentrations of these B. circulans strains. Nonetheless, B. circulans species is not considered a plant or animal pathogen, and in spite of its widespread distribution in the environment, there is no evidence that B. circulans has adversely affected terrestrial invertebrates at the population level. There have been no human infections attributed to B. circulans strain ATCC 9500, and as a species, B. circulans is not known as a human pathogen. Despite its ubiquity, there have been few case reports of human infection with B. circulans, and these occurred mostly in individuals with pre-existing health conditions. B. circulans strain ATCC 9500 is sensitive to different classes of antibiotics including aminoglycosides, glycopeptides, second-generation fluoroquinlones and third-generation cephalosporins which may be used in the unlikely event of infection with this organism.
This assessment considers the aforementioned characteristics of B. circulans strain ATCC 9500 with respect to environmental and human health effects associated with consumer or commercial product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA, as published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice). Information submitted in response to the section 71 notice indicates that B. circulans strain ATCC 9500 is used in consumer and commercial products for biodegradation, drain cleaning and degreasing, septic tank maintenance, as well as waste and wastewater treatment.
Based on the information available, it is proposed to conclude that B. circulans strain ATCC 9500 does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also proposed to conclude that B. circulans strain ATCC 9500 does not meet the criteria under paragraph 64(c) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Proposed conclusion
It is proposed to conclude that B. circulans strain ATCC 9500 does not meet any of the criteria set out under section 64 of CEPA.
The draft screening assessment for this living organism is available on the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca).
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of a living organism — Bacillus megaterium (B. megaterium) strain ATCC (see footnote 14) 14581 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas Bacillus megaterium strain ATCC 14581 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft screening assessment conducted on this living organism, pursuant to paragraph 74(b) of the Act is annexed hereby;
Whereas it is proposed to conclude that this living organism does not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on this living organism at this time under section 77 of the Act.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the draft screening assessment for Bacillus megaterium strain ATCC 14581
Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health (the ministers) have conducted a screening assessment of Bacillus megaterium strain ATCC 14581.
Bacillus megaterium strain ATCC 14581 is a Gram positive bacterium that has characteristics in common with other strains of this species. B. megaterium can be found in both aquatic and terrestrial environments, in association with plants, animals and humans, as a contaminant of foods and in man-made environments. Like other Bacillus species, B. megaterium is able to form thick-walled spores, which can withstand harsh conditions and nutrient depletion. It is also able to form biofilms, allowing it to persist and survive in suboptimal conditions. Various characteristics make B. megaterium suitable for applications in wastewater treatment, bioremediation and biodegradation, cleaning and deodorizing, drain and septic treatment, as well as enzyme and chemical production.
B. megaterium can have both beneficial and adverse effects in terrestrial plants. In Canada, B. megaterium strain ATCC 14581 is not recognized as a plant pest and has been reported to act as a plant growth promoting rhizobacterium. Although B. megaterium or its secondary metabolites can adversely affect some invertebrate species in the context of experimental investigations into their biocontrol potential, B. megaterium strain ATCC 14581 did not cause effects in the terrestrial invertebrate Folsomia candida, and no effects in aquatic plants, invertebrates or vertebrates or terrestrial vertebrates have been reported.
In spite of the widespread distribution of B. megaterium in the environment, human infection with B. megaterium is very rarely reported. Adverse human health effects have not been attributed to B. megaterium strain ATCC 14581 and it does not carry enterotoxin genes which have occasionally been associated with other strains of B. megaterium. Antibiotic susceptibility testing performed by Health Canada scientists demonstrated that, in the unlikely event of infection, clinically relevant antibiotics are effective against this strain.
This assessment considers the aforementioned characteristics of B. megaterium strain ATCC 14581 with respect to the environment and human health effects associated with consumer and commercial product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA, as published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice). Information submitted in response to the section 71 notice indicates that 10 000 to 100 000 kg of products containing B. megaterium strain ATCC 14581 were imported into or manufactured in Canada in 2008. Reported uses include products or activities in the consumer, commercial and industrial sectors.
Based on the information available, it is proposed to conclude that B. megaterium strain ATCC 14581 does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also proposed to conclude that B. megaterium strain ATCC 14581 does not meet the criteria under paragraph 64(c) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Proposed conclusion
It is proposed to conclude that B. megaterium strain ATCC 14581 does not meet any of the criteria set out under section 64 of CEPA.
The draft screening assessment for this living organism is available on the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca).
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of a living organism — Chaetomium globosum (C. globosum) strain ATCC (see footnote 15) 6205 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas Chaetomium globosum strain ATCC 6205 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft screening assessment conducted on this living organism, pursuant to paragraph 74(b) of the Act, is annexed hereby;
Whereas it is proposed to conclude that this living organism does not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on this living organism at this time under section 77 of the Act.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the draft screening assessment for Chaetomium globosum strain ATCC 6205
Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of Chaetomium globosum (C. globosum) strain ATCC 6205.
C. globosum strain ATCC 6205 is a fungus that has characteristics in common with other strains of the species C. globosum. C. globosum is present in many environments. It has been isolated from natural settings such as soil, marine and fresh water, and in association with plants and animals. It is also commonly found on mouldy building materials. C. globosum has properties that are of potential use in biocontrol, plant growth promotion, biodegradation, water and wastewater treatment, drain cleaning and degreasing, and the production of enzymes.
There have been no adverse environmental effects reported in the scientific literature that could be attributed to C. globosum strain ATCC 6205. Members of the species are known to produce several mycotoxins and bioactive secondary metabolites, some of which are harmful to human cell lines and animals, shrimp, mice or rats. Mycotoxin testing of C. globosum strain ATCC 6205 indicated that it produces low levels of mycotoxins relative to other C. globosum strains. There are a few reports of C. globosum acting as a pathogen in aquatic and terrestrial plants, invertebrates and vertebrates. In spite of these studies and reports and its widespread distribution in the environment, there is no evidence that C. globosum has adversely affected any terrestrial or aquatic species at the population level.
As a species, C. globosum is not known as a human pathogen. Despite its ubiquity, there have been only a few confirmed cases of systemic human infection with C. globosum, and these occurred in individuals predisposed to infection because of pre-existing health conditions. C. globosum has been implicated in nail and skin infections in otherwise healthy patients, who often had a history of recent trauma to nail or skin as a predisposing factor. A number of antifungal agents, including clotrimazole, isoconazole, and terbafine, are effective against C. globosum strain ATCC 6205 and may be used should an infection occur.
This assessment considers C. globosum strain ATCC 6205 with respect to environmental and human health effects associated with consumer and commercial product use and industrial processes subject to CEPA, including release to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA, published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice). Information submitted in response to the section 71 notice indicates that C. globosum strain ATCC 6205 is used in biodegradation and research and development.
Based on the information available, it is proposed to conclude that C. globosum strain ATCC 6205 does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also proposed to conclude that C. globosum strain ATCC 6205 does not meet the criteria under paragraph 64(c) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Proposed conclusion
It is proposed to conclude that C. globosum strain ATCC 6205 does not meet any of the criteria set out under section 64 of CEPA.
The draft screening assessment for this living organism is available on the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca).
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of a living organism — Micrococcus luteus (M. luteus) strain ATCC (see footnote 16) 4698 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas Micrococcus luteus strain ATCC 4698 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft screening assessment conducted on this living organism, pursuant to paragraph 74(b) of the Act, is annexed hereby;
Whereas it is proposed to conclude that this living organism does not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on this living organism at this time under section 77 of the Act.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
David Morin
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the draft screening assessment of Micrococcus luteus strain ATCC 4698
Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of Micrococcus luteus strain ATCC 4698.
Micrococcus luteus strain ATCC 4698 is a bacterial strain that shares characteristics with other strains of the species. Micrococcus luteus belongs to the normal flora of mammalian skin and mucous membranes, and is also widespread in the environment, including soil, air, dust, water, polar ice, activated sludge, plants, fish, insects, and food. It has properties that make it of potential use in bioremediation, biodegradation, wastewater treatment, drain cleaning and degreasing, growth promotion of plants and fish, skin treatment, and the production of enzymes and antibiotics.
There is no conclusive evidence in the scientific literature to suggest that M. luteus strain ATCC 4698 is likely to have adverse effects on terrestrial or aquatic plants, vertebrates or invertebrates in the environment. In a Springtail reproduction test conducted with strain ATCC 4698, no significant effects on adult survival or juvenile production were observed. There are a few reports of animal infections attributed to the species M. luteus, which are either too old to verify by using modern identification methods or were polymicrobial with 7–10 other micro-organisms involved. M. luteus was unlikely to be the primary pathogen. Moderate pathogenicity of M. luteus towards an insect pest of hazelnuts was reported under experimental conditions, which are unlikely to occur in nature.
There is no evidence from the scientific literature to suggest that M. luteus strain ATCC 4698 is likely to have adverse effects on human health. In humans, M. luteus is generally considered to be a harmless, non-pathogenic, commensal organism, and is rarely isolated as an opportunistic pathogen from damaged tissues. Early Micrococcus infections were diagnosed using methods that did not differentiate Micrococcus from coagulase-negative Staphylococcus, the more likely agent of infection. The few infections attributable to M. luteus were acquired following a medical procedure that could introduce micro-organisms from the skin into sterile body compartments, including cardiac surgery or use of central venous catheters, often in individuals with debilitating diseases, such as cancer or kidney failure. In the unlikely event of infection, M. luteus is susceptible to most antibiotics.
This assessment considers the aforementioned characteristics of M. luteus strain ATCC 4698 with respect to environmental and human health effects associated with product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA, as published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice). Information submitted in response to the section 71 notice indicates that M. luteus strain ATCC 4698 was not imported into or manufactured in Canada in 2008, except in limited quantities for academic research, teaching, and research and development activities.
Based on the information available, it is proposed to conclude that M. luteus strain ATCC 4698 does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also proposed to conclude that M. luteus strain ATCC 4698 does not meet the criteria under paragraph 64(c) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Proposed conclusion
It is proposed to conclude that M. luteus ATCC 4698 does not meet any of the criteria set out under section 64 of CEPA.
The draft screening assessment for this living organism is available on the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca).
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of final decision after screening assessment of a living organism — Aspergillus oryzae (A. oryzae) strain ATCC (see footnote 17) 11866 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)
Whereas Aspergillus oryzae strain ATCC 11866 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the screening assessment conducted on this living organism, pursuant to paragraph 74(b) of the Act, is annexed hereby;
And whereas it is concluded that this living organism does not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on this living organism at this time under section 77 of the Act.
Notice is further given that the Minister of the Environment intends to amend the Domestic Substances List, under subsection 112(3) of the Act, to indicate that the significant new activities provisions under subsection 106(3) thereof apply with respect to this living organism.
Catherine McKenna
Minister of the Environment
Jane Philpott
Minister of Health
ANNEX
Summary of the screening assessment of Aspergillus oryzae strain ATCC 11866
Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on A. oryzae strain ATCC 11866.
A. oryzae strain ATCC 11866 is a fungus that is a member of the Aspergillus flavus group and has characteristics in common with two members of that group, A. oryzae and A. flavus.
A. oryzae occurs where it is used in food fermentation facilities, primarily in Japan and China, but it may also be found sporadically in soil or on decaying plant materials. A. oryzae is considered by some taxonomists as a group of domesticated strains of A. flavus that have lost the ability to produce aflatoxins, exhibit sparse sporulation and have floccose aerial mycelia. Although genetically almost identical to A. flavus, A. oryzae is classified as a separate species to indicate strains that are suitable for food production. There is no evidence in the scientific literature indicating that A. oryzae is a plant or animal pathogen, although a few cases of infection in animals with predisposing conditions have been reported. Under normal circumstances, it is unlikely to be a serious hazard to healthy livestock or to other organisms in the environment. Information from the scientific literature indicates that A. oryzae is unlikely to cause infection in healthy or debilitated humans.
A. flavus is generally considered to be ubiquitous in nature, and able to thrive in a variety of terrestrial and aquatic habitats. A. flavus is a plant pathogen and is known to cause disease in maize, cottonseed, tree nuts, and oilseed crops. A. flavus has also been reported as an opportunistic animal pathogen, causing mycosis (i.e. infection) mostly in birds and mycotoxicosis (i.e. disease from ingestion of toxin-contaminated feed), which triggers a range of symptoms that can debilitate the host. A. flavus can cause sinus and eye infections in otherwise healthy humans, and potentially fatal lung disease and systemic infections in susceptible groups (i.e. infants and the elderly, the immunocompromised and individuals with debilitating comorbidities).
Both species have been reported infrequently to cause allergic reactions in humans and animals, including hypersensitivity in susceptible individuals.
A. oryzae strain ATCC 11866 was originally selected for high protease production. This property makes it of possible commercial and industrial interest for fermentation, enzyme production, chemical production, as a livestock probiotic, for bioremediation, biodegradation, industrial effluent treatment, municipal wastewater treatment (particularly grease traps and sewer lines), organic waste treatment, biosorption of environmental contaminants and use as a host organism for recombinant protein and enzyme production.
The morphological characteristics of A. oryzae strain ATCC 11866, particularly the small conidial size, which is associated with virulence, more closely resemble those of A. flavus; however, A. oryzae strain ATCC 11866 is not known to produce aflatoxin, and it is susceptible to the major clinical antifungals used to treat aspergillosis. These are mitigating factors in this risk assessment.
This assessment considers the aforementioned characteristics of A. oryzae strain ATCC 11866 with respect to human health and environmental effects associated with product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. A conclusion under CEPA on this living organism is not relevant to, nor does it preclude, assessment of products produced by or containing A. oryzae strain ATCC 11866 as prescribed under the purview of the Food and Drugs Act. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA, as published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice). Information submitted in response to the section 71 notice indicates that A. oryzae strain ATCC 11866 was not imported into or manufactured in Canada in 2008. Based on the information available, A. oryzae strain ATCC 11866 is not currently in commerce in Canada.
Based on the information available, it is concluded that A. oryzae strain ATCC 11866 does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also concluded that A. oryzae strain ATCC 11866 does not meet the criteria under paragraph 64(c) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Conclusion
It is concluded that A. oryzae strain ATCC 11866 does not meet any of the criteria set out under section 64 of CEPA.
Because A. oryzae strain ATCC 11866 is listed on the Domestic Substances List (DSL), its import into and manufacture in Canada is not subject to notification requirements under the New Substances Notification Regulations (Organisms). Since there is a potential concern for susceptible humans with compromised immunity and in some instances potential risk to healthy individuals, there is concern that new activities that have not been identified or assessed could lead to A. oryzae strain ATCC 11866 meeting the criteria set out in section 64(c) of CEPA. Therefore, the Government of Canada intends to amend the DSL, under subsection 112(3) of the Act, to indicate that the Significant New Activity (SNAc) provisions under subsection 106(3) of the Act apply with respect to this living organism.
A significant new activity can include one that has not been conducted with the living organism in the past or an existing one with a different quantity or in different circumstances that could affect the exposure pattern of the living organism. The SNAc provisions trigger an obligation for a person to notify the Minister of the Environment of any new activity and the Government of Canada to assess information about a living organism when a person proposes to use the living organism in a significant new activity. The provisions are used to assess the risks associated with the proposed new activity before the new activity is undertaken. The Minister of the Environment and the Minister of Health assess the information provided by the notifier and other information available to them to determine whether the living organism, if used in the proposed new activity, could pose a risk to the environment or human health, and, if so, whether new or additional risk management is required.
The screening assessment for this living organism is available on the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca).
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of final decision after screening assessment of a living organism — Saccharomyces cerevisiae strain F53 (S. cerevisiae strain F53) — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)
Whereas Saccharomyces cerevisiae strain F53 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the screening assessment conducted on this living organism, pursuant to paragraph 74(b) of the Act, is annexed hereby;
Whereas it is concluded that this living organism does not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on this living organism at this time under section 77 of the Act.
Catherine McKenna
Minister of the Environment
Jane Philpott
Minister of Health
ANNEX
Summary of the screening assessment of Saccharomyces cerevisiae strain F53
Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of Saccharomyces cerevisiae strain F53 (S. cerevisiae strain F53).
S. cerevisiae strain F53 is a yeast that has characteristics in common with other strains of the species S. cerevisiae. S. cerevisiae is known for its fermentative ability and ethanol production. It has been used widely in the bakery and brewery industries; thus, it has been in close association with humans for centuries. Multiple potential uses of S. cerevisiae in consumer, industrial, commercial and agricultural sectors exist. These uses include the production of food, natural health products such as probiotics, feeds, biofuels and biochemicals for the manufacture of cosmetics, perfumes and therapeutic drugs, as well as bioremediation and wastewater treatment. S. cerevisiae can also be present in all of these products.
S. cerevisiae is known to occur in a wide variety of ecological niches, and its use was safe when released into the environment through human activities such as in feed and probiotics for animals, and as an agricultural input for plant growth promotion. There are no reports in the literature implicating the Domestic Substances List (DSL) strain S. cerevisiae strain F53 in causing adverse effects on terrestrial or aquatic plants, invertebrates or vertebrates. However, there are a few reports of pathogenicity attributed to other strains of S. cerevisiae. These include one report of infection in a dog with a history of prolonged antibiotic use, and one report of infection in prawns. S. cerevisiae has also been reported to cause some adverse effects on nematodes.
There have been no reported human infections attributed to S. cerevisiae strain F53; however, certain strains of S. cerevisiae and S. cerevisiae var. boulardii can act as opportunistic pathogens in individuals with compromised immunity or pre-existing medical conditions. In most cases, infections are treated effectively with antifungal compounds. Compared with other opportunistic yeast pathogens like Candida albicans, S. cerevisiae is an organism of low virulence, and rarely causes infections among healthy individuals. Based on Health Canada's in vitro assays, S. cerevisiae strain F53 does not possess putative virulence traits that are generally found in other pathogenic strains; in addition, in vivo pathogenicity testing on six- to eight-week-old BALB/c mice indicated that S. cerevisiae strain F53 does not cause any adverse effects to healthy animals.
This screening assessment considers the aforementioned characteristics of S. cerevisiae strain F53 with respect to environmental and human health effects associated with consumer and commercial product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. A conclusion under CEPA on S. cerevisiae strain F53 is not relevant to, nor does it preclude, the assessment of products generated by or containing S. cerevisiae strain F53 as prescribed under the purview of the Food and Drugs Act.
To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA, as published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice). Information submitted in response to the section 71 notice indicates that S. cerevisiae strain F53 was imported into or manufactured in Canada in 2008 for use in consumer and commercial applications, such as production of foods, feeds and beverages, as well as in research and development.
Based on the information available, it is concluded that S. cerevisiae strain F53 does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also concluded that S. cerevisiae strain F53 does not meet the criteria under paragraph 64(c) of CEPA, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Conclusion
It is concluded that S. cerevisiae strain F53 does not meet any of the criteria set out under section 64 of CEPA.
The screening assessment for this living organism is available on the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca).
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DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of final decision after screening assessment of living organisms — Pseudomonas putida (P. putida) strains ATCC (see footnote 18) 12633, ATCC 31483, ATCC 31800 and ATCC 700369 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)
Whereas Pseudomonas putida strains ATCC 12633, ATCC 31483, ATCC 31800 and ATCC 700369 are living organisms on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the screening assessment conducted on these living organisms pursuant to paragraph 74(b) of the Act is annexed hereby;
And whereas it is concluded that these living organisms do not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on these living organisms at this time under section 77 of the Act.
Notice is further given that the Minister of the Environment intends to amend the Domestic Substances List, under subsection 112(3) of the Act, to indicate that the significant new activities provisions under subsection 106(3) thereof apply with respect to these living organisms.
Catherine McKenna
Minister of the Environment
Jane Philpott
Minister of Health
ANNEX
Summary of the screening assessment of Pseudomonas putida strains ATCC 12633, ATCC 31483, ATCC 31800 and ATCC 700369
Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on four strains of Pseudomonas putida (P. putida) [ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369].
P. putida strains ATCC 12633 (= type strain), ATCC 31483, ATCC 31800 and ATCC 700369 have characteristics in common with other strains of the same species. P. putida is a bacterium generally considered to have ubiquitous distribution in the environment, that can adapt to varying conditions, and that thrives in soil, water and the rhizosphere of many plants. P. putida can also thrive in extreme and contaminated environments with low nutrient availability. Some members of the species P. putida are known to metabolize chemical compounds such as hydrocarbons and solvents. Furthermore, some strains can sequester and reduce heavy metals. These properties allow for potential uses of P. putida in bioremediation and biodegradation, waste water treatment, cleaning and degreasing products, and in the production of enzymes and bio-chemicals used for industrial biocatalysis and in pharmaceuticals.
Despite its widespread presence in soil, water and rhizosphere ecosystems, P. putida has rarely been reported to cause adverse effects in aquatic or terrestrial plants or animals. Some P. putida infections have been reported in captive-bred fish, but rarely in wild fish populations. Overall, there is no evidence to suggest that P. putida has adverse ecological effects at the population level for vertebrates, invertebrates or plants. P. putida is considered a plant growth-promoting rhizobacterium, and some strains have anti-bacterial and anti-fungal properties, making the species of commercial interest in agriculture, and as a biocontrol agent against pest micro-organisms. Overall, there is no evidence specifically implicating the Domestic Substances List (DSL) strains of P. putida (ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369) in adverse effects in the environment.
P. putida infrequently causes infection in healthy humans, but can act as an opportunistic pathogen in individuals predisposed to infection because of compromised immunity or debilitating disease. P. putida colonizes moist surfaces in hospitals, including medical devices and solutions, and can grow at temperatures typical of refrigerated storage. This characteristic has enabled it to proliferate in stored blood products and, in rare cases, cause sepsis in transfused patients. P. putida is resistant to some clinical antibiotics; however, a number of antibiotics are effective in treating P. putida infections. There have been no reported human infections attributed specifically to the DSL strains P. putida ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369.
This assessment considers the aforementioned characteristics of P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 with respect to human health and environmental effects associated with product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA as published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice). Information submitted in response to the section 71 notice indicates that P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 were imported into or manufactured in Canada in 2008 for uses including wastewater treatment and bioremediation.
Based on the information available, it is concluded that P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also concluded that P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 do not meet the criteria under paragraph 64(c) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Conclusion
It is concluded that P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 do not meet any of the criteria set out in section 64 of CEPA.
Because P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 are listed on the DSL, their import and manufacture in Canada is not subject to notification requirements under the New Substances Notification Regulations (Organisms). Since there is a potential risk for susceptible humans with compromised immunity, or those exposed through contaminated medical devices or blood products, there is concern that new activities that have not been identified or assessed could lead to P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, or ATCC 700369 meeting the criteria set out in paragraph 64(c) of CEPA. Therefore, the Government of Canada intends to amend the DSL, under subsection 112(3) of the Act, to indicate that the significant new activity (SNAc) provisions under subsection 106(3) of the Act apply with respect to the living organisms.
A significant new activity can include one that has not been conducted with the living organism in the past, or an existing one with a different quantity or in different circumstances that could affect the exposure pattern of the living organism. The SNAc provisions trigger an obligation for a person to notify the Minister of the Environment of any new activity and the Government of Canada to assess information about a living organism when a person proposes to use the living organism in a significant new activity. The provisions are used to assess the risks associated with the proposed new activity before the new activity is undertaken. The Minister of the Environment and the Minister of Health assess the information provided by the notifier and other information available to them to determine whether the living organism, if used in the proposed new activity, could pose a risk to the environment or human health, and, if so, whether risk management is required.
The screening assessment for these living organisms is available on the Government of Canada's Chemical Substances website (www.chemicalsubstances.gc.ca).
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INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA
Notice of opportunity for the Asia Pacific Economic Cooperation Cross Border Privacy Rules System — Application for recognition as Accountability Agent
Summary
Innovation, Science and Economic Development Canada is giving notice that interested organizations may submit applications to serve as Accountability Agents for Canada under the Asia Pacific Economic Cooperation (APEC) Cross Border Privacy Rules (CBPR) System.
Description
The Asia Pacific Economic Cooperation Cross Border Privacy Rules System (APEC CBPR System) is a voluntary system whereby the cross-border privacy policies and practices of interested organizations in participating APEC member economies are reviewed and certified as compliant with a commonly agreed upon set of program requirements based on the APEC Privacy Framework Information Principles (http://www.apec.org/Groups/Committee-on-Trade-and-Investment/~/media/Files/Groups/ECSG/05_ecsg_privacyframewk.ashx).
Under the CBPR System, the cross-border privacy policies and practices of interested organizations are assessed and certified by a third-party body in the public or private sector, referred to as an Accountability Agent. Only APEC-recognized Accountability Agents may perform CBPR certifications.
The CBPR System includes a dispute resolution system, as well as backstop enforcement through Privacy Enforcement Authorities that are participants in the APEC Cross Border Privacy Enforcement Arrangement (CPEA). The Office of the Privacy Commissioner of Canada is a participant in the CPEA.
Supplementary information
APEC is a regional intergovernmental forum established in 1989 dedicated to promoting free trade and investment, economic growth and development and cooperation in the Asia-Pacific region. APEC aims to create greater prosperity by promoting balanced, inclusive, sustainable, innovative and secure growth and by accelerating regional economic integration. APEC operates on the basis of non-binding commitments and open dialogue.
The 21 APEC member economies are Australia, Brunei Darussalam, Canada, Chile, the People's Republic of China, Hong Kong China, Indonesia, Japan, the Republic of Korea, Malaysia, Mexico, New Zealand, Papua New Guinea, Peru, Philippines, Russia, Singapore, Chinese Taipei, Thailand, the United States and Vietnam.
Process for application
Criteria for recognition
To become an APEC-recognized Accountability Agent, applicants are required to meet the established recognition criteria to the satisfaction of APEC member economies.
These criteria provide for the evaluation of an Accountability Agent applicant's privacy requirements, its policies and procedures for the avoidance of conflicts of interest, dispute resolution procedures, as well as processes related to the certification and re-certification of organizations, ongoing monitoring and compliance reviews, and enforcement of privacy requirements.
The criteria for an applicant to be recognized as an Accountability Agent under the APEC CBPR System are available at http://www.cbprs.org/Agents/CBPRsRequirements.aspx.
Ongoing APEC CBPR System requirements for Accountability Agents can be found at http://www.cbprs.org/Agents/OngoingRequirements.aspx.
Assessment of application
Innovation, Science and Economic Development Canada will review applications for completeness before forwarding them to the Chair of the APEC Electronic Commerce Steering Group, the Chair of the APEC Data Privacy Sub-Group and the Chair of the APEC CBPR System Joint Oversight Panel (JOP). Applications for recognition as Accountability Agents will be reviewed by the APEC CBPR System JOP for compliance with the stated criteria.
Further details on the application process for recognition under the CBPR System can be found at http://www.cbprs.org/Agents/NewAgentProcess.aspx.
PIPEDA-based certification
Applicants may submit proposals for certification based on the requirements of the Personal Information Protection and Electronic Documents Act (PIPEDA), provided that their submission demonstrates how each element of the PIPEDA-based certification meets or exceeds the baseline requirements of the CBPR System, as provided in the CBPR Program Requirements Map, which can be found at https://cbprs.blob.core.windows.net/files/CBPRS%20Program%20Requirements%20Map.pdf.
Timelines
Applications can be submitted from the date of publication of this notice henceforth. There is no closing date for the submission of applications.
APEC recognition will be valid for one year from the date of recognition. Yearly reapplication and consideration by APEC will be required. However, the Accountability Agent's recognition will continue while an application for continued recognition is being considered.
Contact information for applications
Interested organizations must notify Innovation, Science and Economic Development Canada of their intent to seek recognition as an Accountability Agent for Canada under the APEC CBPR System and accompany this notice with a completed application.
Applications should be submitted either by email or mail to the following address using “Application for Recognition as Accountability Agent” in the subject line of the message.
Charles Taillefer
Director
Privacy and Data Protection Policy Directorate
Digital Policy Branch
Innovation, Science and Economic Development Canada
235 Queen Street, 1st Floor
Ottawa, Ontario
K1A 0H5
Email: charles.taillefer@canada.ca
December 13, 2016
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PRIVY COUNCIL OFFICE
Appointment opportunities
We know that our country is stronger — and our government more effective — when decision-makers reflect Canada's diversity. Moving forward, the Government of Canada will use an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous Canadians and minority groups are properly represented in positions of leadership. We will continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.
The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.
Current opportunities
The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council Appointments website (http://www.appointments-nominations.gc.ca/slctnPrcs.asp?menu=1&lang=eng).
| Position | Organization | Closing date |
|---|---|---|
| Member | Canada-Nova Scotia Offshore Petroleum Board | January 23, 2017 |
| Chairperson | Canadian Museum for Human Rights | January 23, 2017 |
| Chairperson | Canadian Museum of History | January 23, 2017 |
| Vice-Chairperson | Canadian Museum of History | January 23, 2017 |
| Chairperson | Canadian Museum of Immigration at Pier 21 | January 23, 2017 |
| Chairperson | Canadian Museum of Nature | January 23, 2017 |
| Permanent Members | Canadian Nuclear Safety Commission | January 29, 2017 |
| Chairperson | Great Lakes Pilotage Authority Canada | February 19, 2017 |
| Clerk of the House of Commons | House of Commons | February 26, 2017 |
| Chief Science Advisor | Innovation, Science and Economic Development Canada | January 27, 2017 |
| Directors | The Jacques Cartier and Champlain Bridges Incorporated | February 3, 2017 |
| Chairperson | Laurentian Pilotage Authority Canada | February 5, 2017 |
| Directors | Marine Atlantic Inc. | February 8, 2017 |
| Member | National Arts Centre Corporation | February 5, 2017 |
| Member | National Energy Board | February 8, 2017 |
| Members | National Film Board | January 29, 2017 |
| Chairperson | National Gallery of Canada | January 23, 2017 |
| Vice-Chairperson | National Gallery of Canada | January 23, 2017 |
| Director of Public Prosecutions | Office of the Director of Public Prosecutions | January 23, 2017 |
| Executive Vice-Chairperson and Member | Parole Board of Canada | February 5, 2017 |
| Chief Public Health Officer | Public Health Agency of Canada | February 12, 2017 |
| Directors | Royal Canadian Mint | January 29, 2017 |
| Member | Telefilm Canada | January 29, 2017 |
| Directors | VIA Rail Canada Inc. | February 8, 2017 |
Upcoming opportunities
| Position | Organization |
|---|---|
| President (Chief Executive Officer) | Atomic Energy of Canada Limited |
| Commissioner for Workers | Canada Employment Insurance Commission |
| Chairperson | Canada Foundation for Innovation |
| President | Canadian Centre for Occupational Health and Safety |
| Chairperson | Canadian International Trade Tribunal |
| Directors | Canadian Race Relations Foundation |
| Citizenship Judges | Citizenship Commission |
| Directors | Farm Credit Canada |
| Directors | First Nations Financial Management Board |
| Sergeant-at-Arms | House of Commons |
| Chairperson | National Battlefields Commission |
| Commissioner | National Battlefields Commission |
| Procurement Ombudsman | Office of the Procurement Ombudsman |
| Chairperson | Patented Medicine Prices Review Board |
| Member | Patented Medicine Prices Review Board |
| Chairperson and Member | Standards Council of Canada |
Ongoing opportunities
| Position | Organization |
|---|---|
| Full-time and Part-time Members | Immigration and Refugee Board |
| Members — All regional divisions (full-time positions and part-time positions) | Parole Board of Canada |
| Full-time and Part-time Members (Appeal Division) | Social Security Tribunal |
| Full-time and Part-time Members (General Division — Employment Insurance Section) | Social Security Tribunal |
| Full-time and Part-time Members (General Division — Income Security Section) | Social Security Tribunal |
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